1. Field of the Invention
The present invention relates to surgical suture-needle packages, and more particularly to a needle shield device for protecting the tip of the needles from damage and to eliminate the possibility of accidental sticking of a person's finger by the needles, as well as to prevent puncturing of the sterile package in which the needles are enclosed during storage and handling.
2. Discussion of the Prior Art
Packaging devices for needles and suture needle assemblies which include protective flaps or covers are well known in the art. These packages generally include a fold over flap or cover which encloses the needles or the needle tips in the package. In many cases, the flap is integrally formed as part of the package so that the flap or cover comprises a tear away portion which exposes the needles upon opening of the package.
The packaging of sutures, particularly sutures having a needle positioned on at least one end of the suture, requires special consideration to eliminate the possibility of puncturing of the sterile package by the needle enclosed therein, as well as to protect a surgeon or surgical team member from accidental sticking during handling while opening the package. It is also desirable to protect the needles themselves after the package is open against damage to the tips.
Typically, the suture is wound on a retainer prior to enclosure within a sterile, moisture-impervious outer package. The retainer may comprise any containment device, and generally is constructed of a fibrous, somewhat rigid material such as paperboard, pressed paper, or a cardboard material. The retainer may be formed as a series of panels which are foldable over each other to secure the suture between the panels. In most cases, the needles are either loosely positioned between the panels or latched to a panel and folded between the panels with the sutures. Examples of retainers which fold a series of panels over onto themselves to secure the sutures and needles therebetween are disclosed in U.S. Pat. No. 3,136,418 to Stacy et al. and U.S. Pat. No. 3,939,969 to Miller et al.
Another type of suture retainer is constructed as a two piece device having a molded plastic bottom tray which includes a coiled passageway. The suture lays in the passageway, and the entire tray is covered by a top cover or layer of a sheet-like material. When needles are provided on the sutures, the needles are usually secured outside the retainer; that is, the sutures are in the passageway of the bottom tray and covered by the top sheet, while the needles are external to the retainer and must be secured by some additional means. Usually, the needles are positioned in a holding member such as a foam needle park. An example of such a retainer is disclosed in U.S. Pat. No. 3,338,401 to Regan, Jr.
In order to maintain the sterility of such a device, the retainer having the needles attached thereto are further packaged in a moisture-impervious package, constructed of metal foil, plastic film or other suitable materials. A disadvantage to this arrangement lies in the fact that the sharp needles directly rest against the inner surface of the outer package, and may puncture the outer package during storage, handling, etc. This will of course destroy the sterility of the suture and needle assembly, and may expose the surgeon or surgical assistant to a hazard involving accidental sticking.
Several tear away type needle covers for use with surgical suture-needle assembly packages are provided in the prior art. These packages generally comprise a panel having either perforations or score lines which facilitate tearing a portion of the panel from the package to expose the needles after the package is opened. After the tear away cover or flap is removed, the needle and suture assembly may be removed from the package in the conventional manner.
In the prior art, several packages having tear away cover flaps are disclosed, such as U.S. Pat. No. 4,063,638 to Marwood. The package disclosed in Marwood comprises a three panel package, where the suture is wound and held at the center panel and the needle is held in an outer panel. A panel having the tear away flap is provided on the outer panel opposite the needle retaining panel, and the tear away flap is folded over the sutures followed by the needle retaining flap. Upon opening the package, the flap is torn away, thus revealing the needle so that the needle may be removed in the conventional manner.
Another type of package prevalent in the prior art provides a fold over flap which covers the needles within the package. When the package is opened, the fold over flap is unfolded to reveal the needles os that the needles may be removed in the conventional manner. Such a device is disclosed in U.S. Pat. No. 4,574,948 to Huck et al. Huck et al. provides a packaging device in which the suture is secured on one panel of the package and the needles are secured on a second panel. A fold over flap is provided to cover the needles to prevent sticking of the user and to prevent damage to the needle tips. As the package is opened, the fold over flap is unfolded to reveal the needles so that the needles may be removed in a conventional manner. A similar type device is disclosed in U.S. Pat. No. 4,708,241 to Black, deceased.
The devices disclosed in the prior art suffer from several disadvantages in which the risk of accidental sticking of the needle into the fingers of the user is not significantly reduced or eliminated, and further, many of these devices suffer the disadvantage in that the cost of packaging is increased due to the necessity for additional packaging material as well as increasing the number of packaging steps during assembly.
Surgical suture-needle retainers and needle packages are generally constructed of a material which resists folding and bending and which is strong enough to hold a coiled suture in place without the risk of the suture unraveling during shipment. The retainer must also be rigid enough to resist bending or folding to eliminate the risk of creasing the suture during shipment, so that when the retainer is opened the suture may be removed from the package without creases or bends. There is significant emphasis in the surgical suture industry placed on the "memory" retention of the suture material, so that the suture retains its original shape upon removal from the retainer with a minimum of bends and creases, even after extended periods of time within the retainer. In view of this, many of the retainers disclosed above which provide a needle retaining member which is folded over the package increase the amount of bends in the suture material during packaging, which may lead to an undesirable suture-needle assembly upon removal from the retainer.
A further disadvantage of the prior art retainers is that in using the retainer itself to protect the needles, such as those retainers disclosed above having a tear away portion, there is a requirement that additional packaging material must be provided to cover the needle given the fact that many of these retainers employ rigid panels, sometimes in laminate form, the cost of packaging is necessarily increased to provide the needle cover. In addition, the step of forming the retainer material must include the addition of score lines or perforations to facilitate the tear feature to expose the needles.
An additional disadvantage to these fold over devices lies in the face that the needles are hidden from view until that portion of the retainer is either torn away or unfolded to reveal the needles. Consequently, the user is at risk of accidentally sticking himself with the needles since he cannot see the needles during the tear away or unfolding step.
The novel needle shield device for surgical retainers and packages having needles or suture-needle assemblies of the present invention obviates the disadvantages encountered in the prior art and provides a universal needle shield device for use with any surgical needle or suture-needle retainer or package. The shield of light weight material and provides the user with protection against sticking while further providing protection for the needle tips against damage. The shield further protects the outer sterile package in which the retainer is enclosed from inadvertent puncture. The needle shield of the present invention may be used with any surgical needle or suture-needle assembly package, and eliminates the requirement for providing additional packaging material and the requirement for complex folding arrangements of the rigid retainer material to cover the needles.